Licence - Registration

In accordance with Regulations (EC) No 273/2004 and 111/2005, as well as the relevant delegated and implementing Regulations ((EU) 2015/1011, 2015/1013, 2016/1443, 2018/729, 2020/1737, 2022/1518, 2023/196, and 2024/1331), the following obligations apply to both operators and users of scheduled substances:

Category 1

• A licence is required for the possession, placing on the market, import, export, or intermediary activities.
• Both operators and users must apply for a licence from the competent authority in advance.
• Intra-EU supplies are permitted only to other authorised operators or users, provided that a signed customer declaration has been obtained.

 
Category 2 (*)

• Registration is mandatory for the placing on the market of Category 2 substances by operators.
• Since 1 July 2015, users must obtain a registration from the competent authority for the possession of substances from subcategory 2A.
• For substances from subcategory 2B, users aren't required to register. If they nonetheless acquire quantities exceeding the established thresholds, they must be able to present a valid customer declaration.
• Operators may only supply these substances within the EU to parties who are registered (with the exception of users of subcategory 2B) and who have signed a valid customer declaration.

(*) Exception: registration and submission of a customer declaration are not required for operators and users of category 2, provided that the total annual quantity remains below the following threshold values (as stated in Annex II of Regulation (EC) No. 273/2004):

Category 3
Registration is required for operators engaged in the export of Category 3 substances.

Exception: registration is not required if, in the previous calendar year (1 January – 31 December), the total quantity exported remained below the following thresholds (as stated in Annex I of Delegated Regulation (EU) 2015/1011). If the thresholds are exceeded in the current year, the operator must immediately comply with the registration requirement.

Category 4
No licence or registration required.

New application
Applications can only be submitted via the designated application form.
Licences or registrations are valid for a maximum of three years and may be renewed.

Amendment
Any changes to the details on the licence or registration must be notified to the FAMHP within 15 days.  If it becomes evident that incorrect data were retained due to failure to report a change, the licence or registration may be suspended or withdrawn.

Amendment requests must be submitted via the amendment form. If the current licence or registration was issued in paper format, the original document must also be returned.

In the case of a change in company name, a completely new application must be submitted. A new licence or registration will then be issued with a new number.

Renewal
A renewal application must be submitted to the Precursor Unit no earlier than six months and no later than three months before the expiry of the licence or registration. This must be done via the renewal form. If the current licence or registration was issued in paper format, the original document must also be returned.

Return the form by post or e-mail
Please complete the application form in full and add the necessary signatures and annexes, otherwise the application will be declared inadmissible. The application form and any supporting documents may be sent

1. By post to:

Federal Agency for Medicines and Health Products
DG Inspection - Authorisations Division - Drug Precursors Unit
Avenue Galilée 5/03
1210 Brussels

2. By e-mail to drugprecursor@fagg-afmps.be   
   Only when provided with qualified electronic signatures (no scan).

Fees
For the initial application and renewal of a licence or registration, a fee is due to the FAMHP. This amount is indexed annually.
Payment is not required in advance; the fee will be invoiced upon issuance of the licence or registration.